12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DentMix VPS Impression Material
FDA 510(k)
FDA Class 2
·Dental
Ryno Lacer Wrist and Thumb Support
FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357238927·
n.a.
FDA UDI
Karl Storz GmbH & Co. KG·04048551077801·Seeker, 25°, 16 cm
Disposable Iris Retract
FDA UDI
KATENA PRODUCTS, INC.·00841668114346·FLEXIBLE IRIS RETRACTORS 5 PKS of 5
MILLEX VV, GV, AND HV SYRINGE FILTER UNITS
FDA 510(k)
FDA Class 2
·Anesthesiology
MEPILEX TRANSFER AG
FDA 510(k)
FDA Unclassified
·Unknown
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 14, 2025
TENDRIL SDX
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·November 10, 2008
ACRYSOF TORIC
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·August 18, 2011
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·July 2, 2013
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026